Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Emergence Agitation
研究概览
简要总结
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
详细描述
Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (<2hr)
排除标准
- •children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection
研究组 & 干预措施
Midazolam
Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
干预措施: Midazolam (Drug)
Ketamine
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
干预措施: Ketamine (Drug)
结局指标
主要结局
Emergence Agitation
时间窗: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.
次要结局
未报告次要终点
研究者
Ki Hwa Lee
Assistant professor
Inje University